- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522402
Effect of Head Position on MACEI of Sevoflurane in Children With Obstructive Airway (MACEI)
May 10, 2018 updated by: Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Effect of Head Position on Minimum Alveolar Concentration of Endotracheal Intubation(MACEI)of Sevoflurane in Children With Obstructive Airway
Children scheduled for tonsillectomy surgery were recruited into the study.
General anesthesia was induced with 8% sevoflurane inhaled with 8 l.min-1 of oxygen via mask, followed by adjustment of inspired sevoflurane to the target concentration based on the result in previous patient at which laryngoscopy and tracheal intubation were attempted and maintained for 12 min.
All responses to tracheal intubation were assessed.
At the end of the procedure, sevoflurane was titrated to the target concentration, which was kept constant for 12 min before a standard stimulus was applied to determine whether the children was awake.
The Dixon's 'up and down'method was used to determine progression of subsequent concentrations.The aim of this study was to determine whether the minimum alveolar concentration of endotracheal intubation(MACEI)of sevoflurane in children with obstructive airway are different from that observed in normal children.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position.
All patients were preoxygenated using 100% oxygen with a normal tidal volumen for 3 min.
The circuit was primed with sevoflurane 8% at a fresh gas flow of 8 Litre/min (L/min) for 1 min.
Anaesthesia was induced with inhaled sevoflurane up to 5% in oxygen via facemask with fresh gas flow at 6 L/min.After loss of consciousness, the inspired concentration of sevoflurane was maintained 10-12min a predetermined end-tidal concentration.
A single experienced anaesthetist in the use of endotracheal devices inserted the devices according to the manufacturer's recommendations.
Neuromuscular blocking agents and other intravenous anesthetics were not given.
One nurse, who was blinded to the anaesthetic concentration, classified responses by the patient to tracheal intubation as either "movement" or "not movement".
Assesment was made for jaw relaxation and graded with intubation score.
The sum of intubation scores >4 was defined as a failure of insertion.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
If the endotracheal device insertion was successful, sevoflurane concentration for the next patient was decrease by 0.5%.
If not, sevoflurane concentration was increased by the same amount for the next patient.
For their comfort, patients experiencing movement received a 2 mg/kg bolus dose of propofol,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg.If the endotracheal device insertion was successful,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg was also administered.
Study Type
Interventional
Enrollment (Anticipated)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Shanghai9 Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- class I or II
- children aged 2-8 years
- children with obstruction airway under general anesthesia undergoing tonsillectomy surgery
- signed informed consent
Exclusion Criteria:
- Patients with a history of adverse reactions to sevoflurane
- Patients with a potentially difficult airway (Mallampati III or IV, a limited mouth opening and/or cervical spine disease)
- Patients with reactive airway disease
- Signs of upper respiratory infection
- Violate experimental scheme
- refused to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 30 degree rotated lateral position
19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in 30 degree rotated lateral position.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
|
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
Other Names:
|
Active Comparator: neutral position
19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in the neutral position.The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
|
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position.
The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method.
The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0
for at least 10 minutes to establish equilibration before device insertion was attempted.
The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
minimum alveolar anesthetic concentration of endotracheal intubation
Time Frame: The sevoflurane concentration is obtained when tracheal intubated immediately.
|
To compare the minimum alveolar anesthetic concentration of endotracheal intubation required for different head position in children with obstructive airway.
|
The sevoflurane concentration is obtained when tracheal intubated immediately.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intubation score
Time Frame: The intubation score is obtained when tracheal intubation was inserted immediately.
|
One nurse, who was blinded to the anaesthetic concentration, classified responses by the patient to tracheal intubation as either "movement" or "not movement".
Assesment was made for jaw relaxation and graded with intubation score.
The sum of intubation scores >4 was defined as a failure of insertion.
|
The intubation score is obtained when tracheal intubation was inserted immediately.
|
blood pressure include systolic and diastolic in mmHg
Time Frame: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
To compare the evolution of blood pressure include systolic and diastolic during different head position group.
|
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
heart rate in bpm
Time Frame: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
To compare the evolution of heart rate during different head position group.
|
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
bispectral index(BIS), number from 100 (awake) to 40-60(anesthetic status)
Time Frame: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
To compare the evolution of of bispectral index values during different head position group.
|
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Li Jing Jie, M.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Thwaites A, Edmends S, Smith I. Inhalation induction with sevoflurane: a double-blind comparison with propofol. Br J Anaesth. 1997 Apr;78(4):356-61. doi: 10.1093/bja/78.4.356.
- Tanaka S, Tsuchida H, Nakabayashi K, Seki S, Namiki A. The effects of sevoflurane, isoflurane, halothane, and enflurane on hemodynamic responses during an inhaled induction of anesthesia via a mask in humans. Anesth Analg. 1996 Apr;82(4):821-6. doi: 10.1097/00000539-199604000-00025.
- Yasuda N, Lockhart SH, Eger EI 2nd, Weiskopf RB, Liu J, Laster M, Taheri S, Peterson NA. Comparison of kinetics of sevoflurane and isoflurane in humans. Anesth Analg. 1991 Mar;72(3):316-24. doi: 10.1213/00000539-199103000-00007.
- Wajima Z, Inoue T, Yoshikawa T, Imanaga K, Ogawa R. Changes in hemodynamic variables and catecholamine levels after rapid increase in sevoflurane or isoflurane concentration with or without nitrous oxide under endotracheal intubation. J Anesth. 2000;14(4):175-9. doi: 10.1007/s005400070001.
- Goff MJ, Arain SR, Ficke DJ, Uhrich TD, Ebert TJ. Absence of bronchodilation during desflurane anesthesia: a comparison to sevoflurane and thiopental. Anesthesiology. 2000 Aug;93(2):404-8. doi: 10.1097/00000542-200008000-00018.
- Helbo-Hansen S, Ravlo O, Trap-Andersen S. The influence of alfentanil on the intubating conditions after priming with vecuronium. Acta Anaesthesiol Scand. 1988 Jan;32(1):41-4. doi: 10.1111/j.1399-6576.1988.tb02685.x.
- Makkar JK, Ghai B, Bhardwaj N, Wig J. Minimum alveolar concentration of desflurane with fentanyl for laryngeal mask airway removal in anesthetized children. Paediatr Anaesth. 2012 Apr;22(4):335-40. doi: 10.1111/j.1460-9592.2011.03712.x. Epub 2011 Oct 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
January 1, 2018
Study Completion (Anticipated)
October 31, 2018
Study Registration Dates
First Submitted
April 30, 2018
First Submitted That Met QC Criteria
May 10, 2018
First Posted (Actual)
May 11, 2018
Study Record Updates
Last Update Posted (Actual)
May 11, 2018
Last Update Submitted That Met QC Criteria
May 10, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-15-T15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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